InterForm Cervical Interbody Cage System

Intervertebral Fusion Device With Bone Graft, Cervical

NEXT ORTHOSURGICAL

The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Interform Cervical Interbody Cage System.

Pre-market Notification Details

• Device ID: K161608
• 510k Number: K161608
• Device Name: InterForm Cervical Interbody Cage System
• Classification: Intervertebral Fusion Device With Bone Graft, Cervical
• Applicant: NEXT ORTHOSURGICAL 3270 CORPORATE VIEW SUITE A Vista, CA 92081
• Contact: Ellen Yarnall
• Correspondent: Ellen Yarnall; NEXT ORTHOSURGICAL 3270 CORPORATE VIEW SUITE A Vista, CA 92081
• Product Code: ODP
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-10
• Decision Date: 2016-09-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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